Resources for Providers

The Amneal PATHways® Patient Support Program is designed to help patients and providers stay on course toward accessible treatment, with resources such as:

The Amneal PATHways® Co-pay Assistance Card

Eligible, commercially insured patients may pay as little as $0 per treatment with an Amneal Biosciences product.

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PATHways® Provider Brochure

Outlines the services offered by the PATHways program so you can be confident in the level of support you and your patients can expect when using an Amneal medication.

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PEMRYDI RTU® Prescriber Brochure

Outlines PEMRYDI RTU® product information, such as storage & preparation, dosing, ordering, and support services offered by Amneal PATHways.

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PEMRYDI RTU® Product Information Sheet

Presents key product attributes for PEMRYDI RTU® as well as ordering and storage and handling information.

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PEMRYDI RTU® Coding and Billing Guide

Provides information about third-party reimbursement for PEMRYDI RTU®, including relevant codes, sample claim forms, and the Amneal PATHways® program.

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For information on enrollment, claims submissions, and reimbursement, go to the PATHways Provider Portal.

Resources for Patients

The Amneal PATHways® Patient Support Program provides enrolled patients with a range of resources and services designed to help them access treatment, including:

The Amneal PATHways® Co-pay Assistance Card

Eligible, commercially insured patients may pay as little as $0 per treatment with an Amneal Biosciences product.

LEARN MORE

PATHways Welcome Guide

Learn what is available to you and how to move your individual treatment path forward.

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PEMRYDI RTU® Patient Brochure

Describes what PEMRYDI RTU® is and the possible side effects and reviews patient support services offered by Amneal PATHways.

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Once your healthcare provider prescribes an Amneal medication, ask about enrolling in the Amneal PATHways® Patient Support Program or download an enrollment form to complete together.

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INDICATIONS

Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

PEMRYDI RTU® is a folate analog metabolic inhibitor indicated:

  • in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
  • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous NSCLC.
  • as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
  • as a single agent for the treatment of patients with recurrent metastatic non-squamous NSCLC after prior chemotherapy.

Limitations of Use:
PEMRYDI RTU® is not indicated for treatment of squamous cell non-small cell lung cancer.

Mesothelioma

PEMRYDI RTU® is indicated in combination with cisplatin for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

IMPORTANT SAFETY INFORMATION

Contraindication

PEMRYDI RTU® is contraindicated in patients with a history of hypersensitivity reaction to pemetrexed.

Warnings and Precautions

  • Myelosuppression: PEMRYDI RTU® may cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of PEMRYDI RTU®.
  • Renal Failure: PEMRYDI RTU® may cause severe and sometimes fatal renal failure. Do not administer when creatinine clearance is less than 45 mL/min.
  • Bullous and Exfoliative Skin Toxicity: Permanently discontinue PEMRYDI RTU® for severe and life-threatening bullous, blistering, or exfoliating skin toxicity.
  • Interstitial Pneumonitis: Withhold PEMRYDI RTU® for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, or fever pending diagnostic evaluation. If pneumonitis is confirmed, permanently discontinue PEMRYDI RTU®.
  • Radiation Recall: May occur in patients who received radiation weeks to years previously; permanently discontinue PEMRYDI RTU® for signs of radiation recall.
  • Embryo-Fetal Toxicity: PEMRYDI RTU® can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

  • The most common adverse reactions (incidence ≥ 20%) of PEMRYDI RTU® when administered as a single agent are fatigue, nausea, and anorexia.
  • The most common adverse reactions (incidence ≥ 20%) of PEMRYDI RTU® when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.
  • The most common adverse reactions (incidence ≥ 20%) of PEMRYDI RTU® when administered with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

Drug Interactions

  • Ibuprofen increased the risk of PEMRYDI RTU® toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage for patients with a creatinine clearance between 45 mL/min and 79 mL/min.

Use in Specific Populations

  • Lactation: Advise not to breastfeed.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Biosciences, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information.

ABOUT PEMRYDI RTU®

PRODUCT INFORMATION & DOSING

REIMBURSEMENT & SUPPORT

RESOURCES

CONTACT US

The content on this site is intended for pharmacy directors and healthcare professionals. Patients may be interested in the patient reimbursement and support information found in the Reimbursement & Support and Resources sections.

© 2024 Amneal Pharmaceuticals LLC. All rights reserved.
PP-PEM-US-0003   12/24

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INDICATIONS

Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

PEMRYDI RTU® is indicated:

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ABOUT PEMRYDI RTU®

PRODUCT INFORMATION & DOSING

REIMBURSEMENT & SUPPORT

RESOURCES

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